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FDA 510(k)

ADAPTERS WITH X-COATING

K-Number: K022918 · 2002-11-27

ApplicantTerumo Cardiovascular Systems Corporation
Decision Date2002-11-27
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADAPTERS WITH X-COATING is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2002-11-27 under 510(k) number K022918. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPTERS WITH X-COATING?

ADAPTERS WITH X-COATING is a medical device that received FDA 510(k) clearance on 2002-11-27. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K022918.

When did ADAPTERS WITH X-COATING receive FDA 510(k) clearance?

ADAPTERS WITH X-COATING received FDA 510(k) clearance on 2002-11-27, under 510(k) number K022918.

Who is the listed applicant for ADAPTERS WITH X-COATING?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADAPTERS WITH X-COATING?

The FDA product code for ADAPTERS WITH X-COATING is DTL.

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Other records listing Terumo Cardiovascular Systems Corporation as applicant

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Related Devices (Code: DTL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131124COLIGNJilin Coronado Medical , Ltd.K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.K120069MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.K113148E-PASSSynexmed(Shenzhen)Company Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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